Flawed science, irregular procedure, unlawful measures

Here is my letter to MEPs who are members of the ENVI committee of the European Parliament.  ENVI meets on 22 […]

Faced with bad science, bad procedure and bad law, what would you do?

Here is my letter to MEPs who are members of the ENVI committee of the European Parliament.  ENVI meets on 22 January to consider the Tobacco Products Directive text (PDF).  The sections that deal with electronic cigarettes are mostly Article 18 with cross-references to other articles.  This letter is my best shot at saying what’s wrong with how the directive addresses e-cigs, please make further suggestions in the comments.

En français via Jacques Le Houezec

__________________ LETTER TEXT ________________

To: Members of the ENVI committee, European Parliament
CC: Substitute members of the ENVI committee
From: Clive Bates

19 January 2014

On Wednesday 22nd January members of the ENVI committee will consider the text for the revised Tobacco Products Directive that has emerged from the trilogue process.  I would like to draw your attention to the significant weaknesses in the text as it applies to e-cigarettes (primarily Article 18, with cross references to other articles).

I hope you will consider speaking, voting or persuading colleagues in favour of recasting the part of the directive relating to e-cigarettes as a new legislative proposal built on credible science, due process and adequate legal base. 

Flawed science

The underpinning science is flawed and misrepresented.  Two individual scientists and a group of scientists have rejected the underlying science in letters to the Commission and key MEPs:

10 January 2014. Dr Konstantinos Farsalinos wrote to the Commision: The European Commission has misinterpreted my scientific research on nicotine in e-cigarettes

12 January 2014. Dr Lynne Dawkins wrote to the Commission: Please do not distort my words to justify your policy

17 January 2014. A group of eminent international experts in nicotine and tobacco science have made a broader challenge: Scientific Errors in the Tobacco Products DirectiveThis group includes: Professor Jean-François Etter, Dr. Konstantinos Farsalinos, Professor Peter Hajek, Dr. Jacques Le Houezec, Dr. Hayden McRobbie, Professor Chris Bullen, Professor Lynn T. Kozlowski, Dr. Mitchell Nides, Professor Riccardo Polosa, Dr. Karl Fagerström, Professor Martin Jarvis, Dr. Lynne E. Dawkins, Dr. Pasquale Caponnetto, Professor Jonathan Foulds.

The scientific errors listed are not trivial and in fact underpin the most controversial aspects of the directive. They related to:

  • Incorrect assertion of ‘equivalence’ between smoking and e-cigarette use
  • Greatly exaggerated toxicity of nicotine
  • Poor understanding of nicotine using behaviour to justify inappropriate tests
  • Inappropriate assertion of user requirement for consistent dosing based on misunderstanding of consumer behaviour
  • Inappropriate approach to risk management (by limiting container size)
  • Incorrect assertions regarding ‘gateway effects’ to exaggerate risks and to justify advertising bans
Irregular procedure
The European Parliament rightly rejected the inappropriate and unlawful classification of e-cigarettes as medicines on 8 October 2013.  However, that abrupt change of direction has not allowed for the proper procedures that should be integral to the EU legislative process, in particular the following:
  • The requirement to consult – there has been no consultation on the new proposals, though the new regulation will affect millions of users and thousands of business and are subject of great controversy among experts. The 2010 consultation simply asked if nicotine containing products should be included in the directive.
  • The requirement to provide reasons – virtually no argument has been offered to justify the measures, and to the extent there is any, it is based on scientific misunderstanding (see above).
  • The requirement to provide an impact assessment – no new assessment has been produced to support the new proposals, yet they could have serious negative effects on users, distort competition in favour of smoking, impose high and unnecessary burdens on businesses and consumers, and have an overall negative impact on health in Europe.
  • The requirement to allow scrutiny – legislative proposals and amendments should be sent to national parliaments for scrutiny with time for parliaments and governments to react. The proposal has changed beyond recognition since it was circulated in December 2012.  If they see it at all, national parliaments will only see it at the very last minute before a deal is done and not through the proper process.
These are not just ‘nice-to-have’ but are requirements of the EU Treaties.  The sidestepping of these requirements is now the subject of a complaint to the European Ombudsman which is set out in detail here: Maladministration in the development of the revision of the Tobacco Products Directive with specific reference to Article 18 on electronic cigarettes – with explicit backing of consumer organisations from Germany, France, Italy, United Kingdom, Poland, Netherlands, Belgium, Denmark and Hungary, with others indicating their support.

Unlawful measures

As well as the unlawful procedural irregularities above, the flawed science and arbitrary unjustified measures cast severe doubt over the lawfulness of key provisions when tested against the principles of proportionality, non-discrimination and adequate legal base.  The internal market legal base (TFEU 114) is intended to promote free movement of goods and competition, with a high level of health protection. In this case the market is in itself highly beneficial to health – e-cigarettes compete with cigarettes, but are are 99-100% less risky. This legal base requires a health justification for departing from the principle of the free movement of goods:
  • Advertising bans. The directive bans many forms of advertising, promotion and sponsorship in many media. Why? Advertising is a service in its own right and integral to free movement of goods. The 2003/33/EC tobacco advertising directive recital (3) refers to 500,000 deaths among Europeans as part of the justification for banning tobacco advertising. There is no equivalent rationale for e-cigarettes – indeed e-cigarette advertising may drive switching from smoking and be beneficial to health. A more proportionate approach would apply the type of restrictions applied to alcohol advertising in member states, not tobacco. Verdict: disproportionate, no health rationale, no legal base.
  • Limiting the strength of liquids. Based on a flawed assertion of the equivalence between cigarettes and e-cigarettes a limit of 20mg/ml has been set for e-liquids, yet 20-30% consumers currently use stronger liquids. What is the health rationale for imposing this limit and denying consumers and producers of stronger liquids access to the internal market?  Stronger liquids matter to more heavily addicted smokers and those just beginning to switch, so this arbitrary limit is more likely to increase relapse and protect the cigarette category. Verdict: discriminatory, no health rationale, no legal base. 
  • Imposing small container sizes. The proposal aims to control acute toxicity risks by limiting the container size.  The reasoning greatly overstates toxicity risks and ignores the widespread practice of controlling hazardous substances through labelling and packaging, not least under the EU Classification, Labelling and Packaging Regulation 1272/2008.  Verdict: discriminatory, no health rationale, no legal base, risk covered by other legislation.
  • Ban on mentioning flavours on flavoured products. The interaction between 18.4(b)ii and 12.1(c) has the effect of banning any reference to flavours on e-cigarette or refill containers, even on products that are flavoured – so depriving everyone involved of legitimate information about the product. Verdict: in legal terms, disproportionate, no legal base. To everyone else, a fiasco.
  • Insisting on consistent ‘dosing’.  This is a matter for consumer preference and has no health rationale given the way consumers use nicotine (see flawed science above), yet it is technically difficult to do. This has been imported from medicines regulation, where drug dosing to passive patients is an important requirement, but it is not appropriate here. Verdict: disproportionate, no health rationale, consumer protection covered by other legislation.
  • Excessive warnings and information leaflets. The warnings are factually incorrect (nicotine is not ‘highly addictive’, it depends how it is administered), excessively large, bold and off-putting given the risks are so low, and potential health benefits so high. The requirement to include an ‘information leaflet’ is not a requirement on cigarette makers. Verdict: discriminatory, disproportionate, no legal base.
  • Requirement for surveillance and pharmacokinetic testing.  There are several costly burdens placed on e-cigarette producers that are not applied to cigarettes. Much information is requested, but it is unclear what will be done with the information supplied. Verdict: discriminatory, disproportionate (fails to meet the requirement to minimise burdens to achieve objectives).
  • Member state discretion. Member states are left with discretion to ban flavours, regulate these products as medicines (another form of ban for most products) or to remove refillable devices from the market. What is the purpose of an EU internal market directive that does little to uphold the principle of free movement of goods? Verdict: will create more arbitrary protection of the cigarette market  and defeats for member states in national courts. 

Missing elements. At the same time, regulation that would actually be useful has been omitted – for example, purity standards for e-liquids or relevant technical standards (eg. operating temperature ranges) for devices.

This focus on e-cigarettes and liquids in this letter reflects the high degree of controversy over the subject during the trilogue. It is not intended to endorse the rest of the directive, notably the ban on snus (Article 15), for which there is no basis whatsoever.  Twelve experts recently wrote to the UK Secretary of State to call for the snus ban to be lifted on scientific, ethical and legal ground

What to do?

The right approach

Taken together, the sections of the TPD that deal with e-cigarettes now total 4,400 words and fill 12 pages – more than enough to justify a new stand-alone EU directive. Most of this text has been created from scratch in the period October to December 2013 with no consultation, inadequate analysis, and poor reasoning based mainly on scientific misunderstandings. It would be better to proceed with a simple amendment of the following form:
Article 18: After completing broad consultations and no later than [31 December 2014] the Commission shall report on the market for non-tobacco recreational nicotine containing products, taking account of health implications and impacts on tobacco consumption. The report shall include policy options and appraisal, and, as appropriate, proposals for legislation to develop the internal market in these products, with the aim of securing a high level of health protection.
The decisions made by the EU on this important and usefully disruptive technology will set the agenda for the next decade or more, and probably set norms internationally. It would be better to get this right, rather than rush through half-baked and very controversial legislation before the May 2014 elections.

The wrong approach

It would be wrong for MEPs to wave through an important component of a directive, knowing it is based on flawed science, following irregular procedures and comprising measures of unlikely legal validity. How could that be justified?  The European Union needs to win trust and respect, not to haemorrhage credibility by passing bad laws and sidestepping the proper constraints of the treaties.

Please contact me if I can provide further information or if you wish to discuss any of the points raised.

Yours sincerely


Clive Bates

__________________ LETTER ENDS ________________

What next?

What’s happening? For guidance on the process that follows next, I recommend the ‘saveecigs’ posting of Martin Callanan MEP: TPD timeline and what happens next.  For a guide to the politics, I recommend the posting of Rebecca Taylor MEP: A deal on e-cigarettes – what next. Her option 1 is the most realistic means of challenging the worst aspects of the directive.

What you can do.  MEPs and MPs can never receive too many tweets, e-mails, letters, phone-calls, visits or any other form of authentic, polite and well-informed representation from constituents and others with a legitimate interest. The ENVI committee membership is here (note there are tabs for members and substitutes. Please handle with care: I recommend carefully targeted mailing).

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14 thoughts on “Flawed science, irregular procedure, unlawful measures”

  1. Great letter as usual Clive. This has recently been brought to my attention:

    I am worried that I am slowly losing my mind, so I need some level headed folk to help me out with this.

    Firstly go here:

    Report on the public consultation on the possible revision of the Tobacco Products Directive (2001/37/EC) and read Para 6.1.1 (page 9)

    Then go here:
    Public Consultation Statistics: compendium

    these are the raw figures from which the first document drew its conclusions, go to Page 24, these are the Government responses – do they support the conclusions or not? Either they have actually lied or I have lost the plot completely.

    Anyone able to interpret this properly, have I missed something here?

    These are the means by which the Impact Assessment justified inclusion into the TPD in the first place……(they ignored the Public data – which is overwhelming). But the government stuff seems just plain old fabrication…

    1. @Roger Anthony Hall – very interesting. I’ve repaired the links now…

      I suspect this is a distinction between the official views of the member states and the views of all government / public sector respondees to the consultation. These numbered 436 but there were only 27 member states at the time. Section 6.6.1 makes this distinction in the responses:

      Reactions from MEPs, National Parliamentarians, and local/regional authority respondents were mixed. Those in favour of extending the scope suggested that the current market of novel products should be regulated, but product bans should only be implemented based on significant scientific evidence. Those against extending the scope of the directive suggested that the EU should develop a concrete scientific assessment process to test the health impacts of new products before making a decision about their availability inside the EU.

      Er… ‘those against extending the scope’ were right.

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  3. Clive, isn’t the real issue with the information not the reply numbers but the fact that the impact assessment data clearly demonstrates that just 17% of the total 436 views believed that the best course of action was to extend the scope of the TPD e.g. include e-cigs. So Art 18 is in direct contravention of the very basic impact assessment questions and the Report on the Public Consultation of which the TPD is based is therefore flawed. In other words how can you include e-cigs within the TPD when the impact assessment’s own data specifically concludes that almost 61% of respondents cited “no change” to the question “Should the scope of the TPD be extended to include e-cigs”.

  4. This is definitely an issue… but they have weighted responses from governments (i.e. the official positions of member states) higher than ‘government responses’ (i.e. anyone describing themselves in a public sector role I guess). But as you say, it is very striking how little support there was for this and how many gave good reasons not just to blunder in with regulation with no clue about the underpinning science.

  5. Pingback: Clive Bates Letter to ENVI commitee Regarding E Cig Regs

  6. Dear Clive, and others. This exact issue (but with regards to snus in the consultation) has already been filed with the ombudsman and discarded as not being maladministration. The “official” country views were to the best of my knowledge collected after it was clear that the official answers in the actual public consultation weren’t to then commissioner Dalli’s liking, and this after construction is not normal procedure for a public consultation. The “file” of the 436 replies has been formatted as to make quite impossible any form of data mining. I have gone through the entire file manually, took quite a long time. Over 65% of replies suggest lifting ban on snus. If you add those respondents who left this option blank (presumably because they were neutral) the figure is just over 80%. In effect 20% of 436 replies were for keeping or expanding the ban on snus. Solid majority if I ever saw one ;)

    1. The argument is that the 2010 consultation was about something else – none of the measures under consideration, or even the basic concepts, were includied.

      I agree the presentation of consultation findings is opaque – I don’t know if that is deliberate or merely negligent

  7. Ah, agreed. My point was simply to point out that the entire process has been demonstrated to be so very deeply flawed right from the beginning to the extent that the current after-constructions etc simply cannot become functional legislation. The only proper thing to do would be to start over from the beginning with a clean sheet and less preconceptions.

  8. Clive,
    As an anti-smoker, talking about flawed science and irregular procedure, are you aware of this, in relation to a report on the dangers of passive smoking by the Environment Protection Agency (EPA) in the USA? I was truly shocked that similar tactics were used against passive smoking as are now being used against e-cigs:

    “In 1998, five years after a law suit was filed by the tobacco industry, US District Court Judge W.L. Osteen invalidated EPA’s (1993) conclusion that secondhand smoke is a human carcinogen and, thus, vacated Chapters 1 through 6 (and related Appendices) of the EPA Report (1993). Amongst other impropriety Judge Osteen found that “EPA publicly committed to a conclusion before research had begun, excluded industry by violating [statutory] procedural requirements; adjusted established procedure and scientific norms to validate the Agency’s public conclusion, and aggressively utilized [statutory] authority to disseminate findings to establish a de facto regulatory scheme intended to restrict Plaintiff’s products and to influence public opinion”; He also concluded that “in conducting the ETS Risk Assessment, EPA disregarded information and made findings on selective information, did not disseminate significant epidemiologic information; deviated from its Risk Assessment Guidelines; failed to disclose important findings and reasoning; and left significant questions without answers. EPA’s conduct left substantial holes in the administrative record. While so doing, EPA produced limited evidence, then claimed the weight of the Agency’s research evidence demonstrated ETS causes cancer.”

    This was taken from “The Godber Blueprint” article – long but fascinating reading about the appalling history of the anti-smoking brigade, including the World Health Organisation. I find the e-cigs issue is turning me into a political animal, much to my astonishment!

    I also read this interesting article from 2003, on the study (buried?) that confirmed that the risks from passive smoking have been hugely exaggerated.
    What’s going on!??!?

  9. Pingback: Totally Wicked legal challenge to the Tobacco Products Directive e-cigarette measures « The counterfactual

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